Health TidingsFDA to Puts Peptides Back Under Scientific Review FDA to Puts Peptides Back Under Scientific Review Read Post »
Health TidingsImmutep Win Orphan Drug Designation for Eftilagimod Alfa in STC Immutep Win Orphan Drug Designation for Eftilagimod Alfa in STC Read Post »
Health TidingsBIZENGRI Steps into the Breach: A Targeted Push Against Rare Bile Duct Canc... BIZENGRI Steps into the Breach: A Targeted Push Against Rare Bile Duct Canc... Read Post »
Health TidingsArbutus Moves Imdusiran Forward Under FDA Fast Track for HBV Arbutus Moves Imdusiran Forward Under FDA Fast Track for HBV Read Post »
Health TidingsLEO Pharma Breaks New Ground as ANZUPGO Moves Toward Pediatric Approval for... LEO Pharma Breaks New Ground as ANZUPGO Moves Toward Pediatric Approval for... Read Post »
Health Tidings Mergers & AcquisitionsIllumina and D3b Construct a Unified Genomic Core to Break Pediatric Data S... Illumina and D3b Construct a Unified Genomic Core to Break Pediatric Data S... Read Post »
GenericsOrbicular–Apotex–Gland Seal the First-Market Vault with CGT Exclusivity... Orbicular–Apotex–Gland Seal the First-Market Vault with CGT Exclusivity... Read Post »
Health TidingsPartnership Capital Fuels Lenacapavir’s Surge into the HIV Prevention Fro... Partnership Capital Fuels Lenacapavir’s Surge into the HIV Prevention Fro... Read Post »
Health TidingsDARZALEX Powers Past Expectations with $3.96 Billion Q1 Sales Surge DARZALEX Powers Past Expectations with $3.96 Billion Q1 Sales Surge Read Post »
Health TidingsPraxis Enters FDA Review Arena With Ulixacaltamide for Essential Tremor Praxis Enters FDA Review Arena With Ulixacaltamide for Essential Tremor Read Post »
Health TidingsBioVersys and GSK’s AlpE Rewires Drug-Resistant Tuberculosis in Preclinic... BioVersys and GSK’s AlpE Rewires Drug-Resistant Tuberculosis in Preclinic... Read Post »
Health TidingsFDA Shines a Floodlight on Hidden Trial Data, Urges Sponsors to Report Miss... FDA Shines a Floodlight on Hidden Trial Data, Urges Sponsors to Report Miss... Read Post »
Health TidingsPriority Review Signals Momentum for Ifinatamab Deruxtecan in ES-SCLC Priority Review Signals Momentum for Ifinatamab Deruxtecan in ES-SCLC Read Post »
Health TidingsGenmab Advances Rina-S Combination After Clean Safety Readout Genmab Advances Rina-S Combination After Clean Safety Readout Read Post »
Health TidingsJaypirca Triple Combo Delays Relapse in Phase 3 CLL Trial Jaypirca Triple Combo Delays Relapse in Phase 3 CLL Trial Read Post »
Health TidingsRoche’s Vabysmo Breaks the Six-Month Ceiling in RVO Care Roche’s Vabysmo Breaks the Six-Month Ceiling in RVO Care Read Post »
GenericsApotex Strikes First in U.S. Semaglutide Generic Push Apotex Strikes First in U.S. Semaglutide Generic Push Read Post »
Health TidingsReplimune Hit With FDA CRL for RP1–Nivolumab in Advanced Melanoma Replimune Hit With FDA CRL for RP1–Nivolumab in Advanced Melanoma Read Post »
Health TidingsFibroBiologics Thymic Organoid (“Artificial Thymus”) Restores Immune Fu... FibroBiologics Thymic Organoid (“Artificial Thymus”) Restores Immune Fu... Read Post »
Health TidingsMacroGenics Regains Momentum as FDA Lifts Hold on LINNET Trial MacroGenics Regains Momentum as FDA Lifts Hold on LINNET Trial Read Post »
ManufacturingGSK Ends Wellcovorin Era as FDA Withdraws Leucovorin NDA After Discontinuat... GSK Ends Wellcovorin Era as FDA Withdraws Leucovorin NDA After Discontinuat... Read Post »
Health TidingsVanda Challenges FDA Legislative Proposal on NDA Timelines and Appeals Vanda Challenges FDA Legislative Proposal on NDA Timelines and Appeals Read Post »
GenericsZenyaku Kogyo to Take Sole Control of Rituxan Sales in Japan After Chugai E... Zenyaku Kogyo to Take Sole Control of Rituxan Sales in Japan After Chugai E... Read Post »
Health TidingsEMA Update Enables Non-Cold-Chain Final Delivery for Wegovy in Europe EMA Update Enables Non-Cold-Chain Final Delivery for Wegovy in Europe Read Post »
Health TidingsLilly Expands Obesity Portfolio With Foundayo Market Launch Lilly Expands Obesity Portfolio With Foundayo Market Launch Read Post »
Generics Women & Child HealthGlenmark Expands U.S. Women’s Health Portfolio with FDA Approval of Gener... Glenmark Expands U.S. Women’s Health Portfolio with FDA Approval of Gener... Read Post »
CROFortrea Leans into AI and Automation With New FIT Clinical Technology Suite Fortrea Leans into AI and Automation With New FIT Clinical Technology Suite Read Post »
Health TidingsBioengineered Liver Therapy miroliverELAP Receives FDA RMAT Designation Bioengineered Liver Therapy miroliverELAP Receives FDA RMAT Designation Read Post »
Health TidingsFDA Fast Track Designation Granted to SIM0505 for Resistant Ovarian Cancer FDA Fast Track Designation Granted to SIM0505 for Resistant Ovarian Cancer Read Post »
GenericsBiocon and Zydus Receive U.S. FDA Approval for Generic Dapagliflozin Tablet... Biocon and Zydus Receive U.S. FDA Approval for Generic Dapagliflozin Tablet... Read Post »
Health TidingsOutlook Therapeutics Challenges CRL with FDA Dispute Request for LYTENAVA Outlook Therapeutics Challenges CRL with FDA Dispute Request for LYTENAVA Read Post »
GenericsBiocon Rolls Out Bosaya, Aukelso Denosumab Biosimilars Across U.S. Biocon Rolls Out Bosaya, Aukelso Denosumab Biosimilars Across U.S. Read Post »
Health Tidings Mergers & AcquisitionsHalozyme and Vertex Sign Global Licensing Deal for Hypercon Drug Delivery T... Halozyme and Vertex Sign Global Licensing Deal for Hypercon Drug Delivery T... Read Post »
Health Tidings Mergers & AcquisitionsBiogen Licenses Alloy AntiClastic ASO Technology Biogen Licenses Alloy AntiClastic ASO Technology Read Post »
Health Tidings Mergers & AcquisitionsAC Immune Expands Tau Program Under Lilly Agreement AC Immune Expands Tau Program Under Lilly Agreement Read Post »
ManufacturingFDA Issues Warning Letter Over Illegal Online Sale of Unapproved GLP-1 Weig... FDA Issues Warning Letter Over Illegal Online Sale of Unapproved GLP-1 Weig... Read Post »
Health TidingsNuvalent Submits FDA NDA for Neladalkib in Pretreated ALK-Positive NSCLC Nuvalent Submits FDA NDA for Neladalkib in Pretreated ALK-Positive NSCLC Read Post »
Health TidingsSavara Secures UK Accelerated Review for MOLBREEVI in Autoimmune PAP Savara Secures UK Accelerated Review for MOLBREEVI in Autoimmune PAP Read Post »
Health TidingsApnimed Secures Up to $150M Financing for Planned AD109 OSA Therapy Launch Apnimed Secures Up to $150M Financing for Planned AD109 OSA Therapy Launch Read Post »
Health TidingsOncolytics to Discuss Pivotal Pelareorep Study in Late-Line Anal Cancer wit... Oncolytics to Discuss Pivotal Pelareorep Study in Late-Line Anal Cancer wit... Read Post »
Health TidingsMedicus Files Optimized Phase 2 Design for Teverelix in AURr Medicus Files Optimized Phase 2 Design for Teverelix in AURr Read Post »
Health TidingsImmunityBio Says ANKTIVA TV Ad Never Aired, Removes Podcast ImmunityBio Says ANKTIVA TV Ad Never Aired, Removes Podcast Read Post »
GenericsNRx Preservative-Free Ketamine ANDA Advances After FDA Labeling Feedback NRx Preservative-Free Ketamine ANDA Advances After FDA Labeling Feedback Read Post »
Health Tidings Mergers & AcquisitionsNeurocrine to Acquire Soleno, Strengthening Rare Disease Portfolio with VYK... Neurocrine to Acquire Soleno, Strengthening Rare Disease Portfolio with VYK... Read Post »
Medical DevicesUK and US Advance Joint Framework for Medical Device Regulation UK and US Advance Joint Framework for Medical Device Regulation Read Post »
Health TidingsShionogi Takes Full Control of RADICAVA in $2.5B Deal with Tanabe Pharma Shionogi Takes Full Control of RADICAVA in $2.5B Deal with Tanabe Pharma Read Post »
Health TidingsMerck Begins Registrational Phase 2b/3 Study of MK-8748 in NVAMD Merck Begins Registrational Phase 2b/3 Study of MK-8748 in NVAMD Read Post »
Health Tidings Mergers & AcquisitionsRegeneron Partners with TriNetX to Leverage 300 Million Patient Records for... Regeneron Partners with TriNetX to Leverage 300 Million Patient Records for... Read Post »
Health TidingsTrump Administration Targets Patented Drug Imports with Conditional Tariffs... Trump Administration Targets Patented Drug Imports with Conditional Tariffs... Read Post »
